Tubing assembly and signal generator placement control device and method for use with catheter guidance systems

ABSTRACT

A tubing assembly having a signal generator placement control device for use in conjunction with electronic catheter guidance systems. The control device facilitates control of the position the guidance systems&#39; signal generator relative to the end of the tubing assembly. The tubing assembly includes a tubular insulator coupled to one end of the control device, and the tubing assembly includes a tubular connector attached to the other end of control device. Also, the tubing assembly includes a catheter attached to the tubular connector and an end member attached to the catheter.

BACKGROUND OF THE INVENTION

Physicians and other health care providers frequently use catheters totreat patients. The known catheters include a tube which is insertedinto the human body. Certain catheters are inserted into through thepatient's nose or mouth for treating the gastrointestinal tract. Thesecatheters, sometimes referred to as enteral catheters, typically includefeeding tubes. The feeding tube lies in the stomach or intestines, and afeeding bag delivers liquid nutrient, liquid medicine or a combinationof the two to the patient.

Other types of catheters are inserted into the patient's veins orarteries for treating the cardiovascular system. These cathetersinclude, among others, the central venous catheter, peripheral venouscatheter and the peripherally inserted central catheter (PICC). Thesecatheters include a relatively small tube that passes through thepatient's veins or arteries. The health care provider uses thesecatheters to provide patients with injections of medications, drugs,fluids, nutrients, or blood products over a period of time, typicallyseveral weeks or more.

When using these known catheters, it is important to place the end ofthe catheter at the proper location within the human body. Erroneousplacement of the catheter tip may injure or harm the patient. Forexample, if the health care provider erroneously places an enteralcatheter into the patient's lungs, liquid may be introduced into thelungs with harmful results. If the health care provider erroneouslyplaces a catheter into the wrong cavity of the cardiovascular system,the patient may experience infection or a harmful blockage.

In some cases, health care providers use X-ray machines to gatherinformation about the location of the catheters within the body. Thereare several of disadvantages with using X-ray machines. For example,these machines are relatively large and heavy, consume a relativelylarge amount of energy and may expose the patient to a relatively highdegree of radiation. Also, these machines are typically not readilyaccessible for use because, due to their size, they are usuallyinstalled in a special X-ray room. This room can be relatively far awayfrom the patient's room. Therefore, health care providers can find itinconvenient to use these machines for their catheter procedures.Furthermore, it can be inconvenient to transport these machines to apatient's home for home care catheter procedures.

Accordingly, there is a need to overcome each of these disadvantages.

SUMMARY OF THE INVENTION

The present invention generally relates to a tubing assembly for acatheter position guidance system. The catheter guidance system is usedto help guide a catheter to a position located within the body. Thesystem can be used during enteral, parenteral or other suitable catheterfeeding applications.

In one embodiment, the catheter guidance system includes a signalgenerator attached to the end of a wire assembly or stylet. The tubingassembly of the present invention houses the signal generator and thestylet while the signal generator is in the body. The tubing assemblyincludes a tubular insulator, a mid-connector or union device which isconnected to the tubular insulator, a y-port connector that attaches tothe union device and a feeding tube or other catheter connected to they-port connector.

The mid-connector or union device enables assemblers to conveniently setthe position of the signal generator at the proper location within thecatheter. This function of the union device enables a stylet of a setlength to be used with catheters of variable lengths. Therefore, thetubing assembly, used in conjunction with the catheter position guidancesystem of the present invention, provides an enhancement in catheterplacement during medical treatment.

It is therefore an advantage of the present invention to provide atubing assembly and signal generator placement control device and methodfor use with catheter guidance systems.

Another advantage of the present invention is to assist the user inproperly placing a catheter end within the body.

Still another advantage of the present invention is to reduce the amountof time necessary to properly guide a catheter to a desired cavitywithin the body.

Yet another advantage of the present invention is to reduce the amountof radiation exposure associated with machines that assist in catheterplacement.

Another advantage of the present invention is to reduce the likelihoodof harm caused by placing a catheter within the body.

Yet another advantage is to simplify the process of catheter placementprocedures.

Still another advantage of the present invention is to increase thesafety of catheter placement procedures.

Another advantage of the present invention is to adapt catheters ofvariable lengths to receive an electronic stylet of a pre-set length.

Yet another advantage of the present invention is to assist health careproviders in guiding and locating catheters within the body at thepatient's bedside.

Another advantage of the present invention is to increase theconvenience of obtaining catheter placement information during and afterplacement of a catheter.

Additional features and advantages of the present invention aredescribed in, and will be apparent from, the following DetailedDescription of the Invention and the figures.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a perspective view of the catheter position guidance systemillustrating the display device, electronic catheter unit and hand-heldtransceiver being used to position a catheter within a patient in oneembodiment of the present invention.

FIG. 2 is schematic block diagram of the electronic configuration of thecatheter position guidance system illustrating the processor, memorydevice, signal generator, input devices and output devices in oneembodiment of the present invention.

FIG. 3 is a top or plan view of the electronic catheter unit and thedisplay device illustrating an enteral application involving a catheterinserted into a human body and indication of catheter information on thedisplay device.

FIG. 4 is a top or plan view of the electronic catheter unit and thedisplay device illustrating a parenteral application involving acatheter inserted into a human body and indication of catheterinformation on the display device.

FIG. 5 is a perspective view of the electronic catheter unitillustrating the tubing assembly and the signal generator being receivedby and housed in the tubing assembly in one embodiment of the presentinvention.

FIG. 6 is a perspective view of the electrical connector of theelectronic catheter unit removed from the tubing assembly illustratingthe tubular connection, union device, y-port connection, feeding tubeand tip of the tubing assembly in one embodiment of the presentinvention.

FIG. 7 is a cross-section view of the tubular insulator housing the wireassembly taken substantially along line VII-VII of FIG. 5.

FIG. 8A is a perspective view of the union device in one embodiment ofthe present invention.

FIG. 8B is a cross-section view of the generator position control deviceor union device taken substantially along line VIIIB-VIIIB of FIG. 8A.

FIG. 9 is a top or plan view of the proximal end of the union device inone embodiment of the present invention.

FIG. 10 is a perspective view of the y-port connector illustrating thefeeding branch, medicine branch, connection branch and flexible arms inone embodiment of the present invention.

FIG. 11 is a cross-section of the y-port connector taken substantiallyalong line XI-XI of FIG. 10.

FIG. 12 is a perspective view of the y-port connector and feeding tubeattached to the connection branch of the y-port connector in oneembodiment of the present invention.

FIG. 13 is a perspective view of the end member or tip of the catheterin one embodiment of the present invention.

FIG. 14 is a perspective view of the signal generator illustrating thetubular insulator housing a portion of the wire assembly in oneembodiment of the present invention.

FIG. 15 is a perspective view of the electrical connector of the signalgenerator illustrating the electrical connector coupled to theelectrical extension extending from the housing in one embodiment of thepresent invention.

FIG. 16 is a top perspective view of the electrical connector of thesignal generator illustrating the top and bottom surfaces, circuitboard, the contact members on the circuit board, the copper wiresattached to the contact members and the elongated stiffener in oneembodiment of the present invention.

FIG. 17 is a bottom view of the electrical connector of the signalgenerator in one embodiment of the present invention.

FIG. 18 is a top or plan view of the circuit board of the electricalconnector of the signal generator in one embodiment of the presentinvention.

FIG. 19 is a perspective view of the signal generator in one embodimentof the present invention.

FIG. 20 is a perspective view of the magnetic field generatorillustrating the coils surrounding the signal booster in one embodimentof the present invention.

FIG. 21 is a top or plan view of an electronic catheter not having thestop member or position controller of the present invention illustratingan example of a magnetic field generator improperly extending beyond theopening of the catheter.

FIG. 22 is another view of an electronic catheter not having the stopmember or position controller of the present invention illustrating anexample of a signal generator improperly positioned with respect to theopening of the catheter.

FIG. 23 is a top or plan view of different sized catheters illustratingvarying positions of the magnetic field generator near the tip of thecatheter due to manufacturing variations among the catheters.

FIG. 24 is a perspective view of the union device and the tubularinsulator illustrating a user inserting the distal end of the tubularinsulator into the union device.

FIG. 25 is a perspective view of the union device and the tubularinsulator illustrating a user adjusting the position of the magneticfield generator within the feeding tube by placing the distal end of thetubular insulator at various positions within the union device.

DETAILED DESCRIPTION OF THE INVENTION I. Catheter Position GuidanceSystem

Referring now to the drawings, in an embodiment illustrated in FIGS. 1and 2, the catheter position guidance system or catheter guidance system2 includes: (a) an apparatus 10 having a housing 18 which supports acontroller or processor 20 and a display device 22; (b) a non-invasivemovable receiver-transmitter or transceiver 32 electronically coupled tothe processor 20 by a wire, cable, signal data connection or signalcarrier 62; (c) a power chord 27 that couples the apparatus 10 to apower source 25; (d) a printer 28 coupled to the apparatus 10 forprinting out paper having graphics which indicate catheter locationinformation; and (e) an invasive electronic catheter unit 12 incommunication with the transceiver 32 and operatively coupled to theapparatus 10 by a wire, cable, chord or electrical extension 34, which,in turn, is operatively coupled to the processor 20. It should beappreciated that the transceiver 32 can include a device which has aseparate signal receiver and signal transmitter. The transceiver 32 canalso include a single device which functions so as to receive andtransmit signals.

As best illustrated in FIG. 2, the system 2, in one embodiment,includes: (a) a plurality of input devices 17 for providing inputsignals to the system 2 such as one or more control buttons 29, a touchscreen 31 and the transceiver 32; (b) a signal generating assembly 16which produces or generates electronic signals that are received by thetransceiver 32; (c) a memory device 21 including machine readableinstructions and one or more computer programs (which, for example, mayinclude a plurality of algorithms 23) which are used by the processor 20to process the signal data produced by the signal generating assembly 16and transmitted by the transceiver 32; and (d) a plurality of outputdevices 19 such as the display device 22 and the printer 28 whichindicate the catheter information to the health care provider. Thedisplay device 22 may be any suitable display mechanism including, butnot limited to, a liquid crystal display (LCD), light-emitting diode(LED) display, cathode-ray tube display (CRT) or plasma screen.

Health care providers can use the system 2 in a variety of catheterapplications. In one example illustrated in FIG. 3, the system 2 is usedin an enteral application. Here, a portion 70 of the electronic catheterunit 12 is placed through the patient's nose or mouth 72. The distal endor tip 60 of the unit 12 is positioned in the stomach 74. The healthcare provider places the transceiver 32 over the chest area 76 of a body78. The display device 22 and the printer 28 indicate informationrelated to the location of the portion 70 of the electronic catheterunit 12 within the body 78, as well as information related to the shapeof the pathway taken by the catheter unit 12. It should be appreciatedthat the system 2 need not indicate the exact location or path of thecatheter unit 12 to provide assistance to the health care provider.

In another example illustrated in FIG. 4, a portion 71 of the electroniccatheter unit 12 is introduced into the patient's body 78 through a veinor artery 73 leading to the heart 75. Similar to the enteral example,the system 2 assists the health care provider in guiding the portion 71of the unit 12 in the patient's vein or artery 73 to a desired cavity inthe heart 75 in preparation for parenteral feeding.

II. Electronic Catheter Unit

Referring to FIG. 5, in one embodiment, the electronic catheter unit 12includes a tubing assembly 14 which receives and houses the signalgenerating assembly 16.

A. Tubing Assembly

As best illustrated in FIGS. 6-7, in one embodiment, the tubing assembly14 includes: (a) a tube or an electrical tubular insulator 40; (b) amid-connector or union device 42 which receives the tubular insulator40; (c) a multi-port connector or y-port connector 44 attachable to theunion device 42; (d) a catheter 50, such as a feeding tube, connected tothe y-port connector 44; and (e) a catheter end, bolus or tip 60attached to the distal end of the catheter 50.

In one embodiment, the tubular insulator 40 includes a tube having: (a)a proximal end 100 attachable to an attachment member or neck 108 of theelectronic catheter unit 12; (b) a distal end 102 receivable by theunion device 42; (c) an internal diameter 104 which is substantiallyequal to or greater than an external diameter 110 of a wire assembly 38described below so as to slide over the wire assembly 38; and (d) anexternal diameter 106. In another embodiment, the tubular insulator 40may fit relatively tightly over the wire assembly 38 so as to be securedto the wire assembly 38.

As best illustrated in FIGS. 8A, 8B and 9, in one embodiment, the uniondevice 42 includes: (a) a proximal end 116; (b) a distal end 118; (c) aposition adjuster, extender or elongated neck 120 positioned between theproximal end 116 and the distal end 118; (d) a grasp or gripping member122 positioned adjacent to the distal end 118 so as to assist users ingrasping and manipulating the union device 42; (e) an insert 124positioned adjacent to the gripping member 122 which is received by they-port connector 44; and (f) an internal surface 126 having a blockingmember or stop 132 which prevents the tubular insulator 40 from passingthrough the end 118. The gripping member 122 includes a plurality ofprotruding walls or ribbed members 136 protruding from a surface 123 ofthe gripping member 122 assisting the user in grasping the union device42. In alternative embodiments, the surface 123 of the gripping member122 may be rough or include other suitably shaped protrusions.

The proximal end 116 of the union device 42 has an internal diameter 128and an external diameter 130. When assembled, the proximal end 116 ofthe union device 42 is coupled to the distal end 102 of the tubularinsulator 40. In one embodiment, the internal diameter 128 of theproximal end 116 of the union device 42 is substantially equal to orlarger than the external diameter 106 of the distal end 102 of thetubular insulator 40. Referring back to FIG. 6, this enables a portion103 of the distal end 102 of the tubular insulator 40 to be movablyreceived by the elongated neck 120 of the union device 42. As describedabove, the stop 132 (having a diameter 133) of the union device 42prevents the distal end 102 of the tubular insulator 40 from passingthrough the distal end 118 of the union device 42.

Referring to FIGS. 10-11, in one embodiment, the multi-port or y-portconnector 44 includes: (a) a body 140; (b) a liquid delivery branch,medicine delivery branch or medicine branch 142 attached to the body 140for distributing drugs, medicine or other medicinal liquids to thepatient; (c) a nutrient delivery branch or feeding branch 144 attachedto the body 140 and sized to receive the insert 124 of the union device42; (d) a catheter or feeding tube connection branch 146 attached to thecatheter 50; (e) a flexible or movable arm 148 attached to the body 140;and (f) a flexible or moveable arm 150 attached to the body 140. In analternative embodiment, y-port connector 44 includes additional branchesfor administering various nutrients or medicines to the body 78. Inanother alternative embodiment, the y-port connector 44 includes only afeeding branch 144 and a connection branch 146. The arm 148 has astopper 152, and the arm 150 has a stopper 154. The stoppers 152 and 154are sized to prevent fluid from passing through the branches 142 and 144after such branches 142 and 144 are plugged with stoppers 152 and 154,respectively. In addition, the arm 150 includes a fastener 155 whichsecures a tube-size adapter 156 to the arm 150. The tube-size adapter156 enables fluid delivery tubes (not shown) having various diameters toconnect to the feeding branch 144 of the y-port connector 44.

As illustrated in FIGS. 12-13, in one embodiment, the catheter 50includes a feeding tube with a body 160 having: (a) a proximal end 162attached to the catheter connection branch 146 of the y-port connector44; (b) a distal end 164; and (c) an external surface 166. The proximalend 162 is insertable into the catheter connection branch 146 of they-port connector 44 so as to bring the catheter 50 into fluidcommunication with the y-port connector 44. In one embodiment, theexternal surface 166 has a plurality of volumetric, measurement or unitmarkings 168 uniformly spaced along the body 160 of the catheter. Thesemarkings 168 assist the user in measuring the flow or distribution ofliquid to or from the patient. In an alternative embodiment, markings168 function as placement markers which assist the user in assessing thedepth that the catheter is placed within the human body.

As best illustrated in FIG. 13, in one embodiment, the end member, bolusor tip 60 is attached to the distal end 164 of the catheter 50. The tip60 includes a body 172 having a collar 174 and an end member 176. Thebody 172 defines a passage 178 and an opening 180. The opening 180 ispositioned between the collar 174 and the end member 176. A portion 177of the end member 176 can have a rounded shape. The shape of the passage178 and opening 180 of the tip 60 is configured to facilitate the flowof fluid from the catheter 50 into the patient's body while decreasingthe likelihood that the opening 180 will become clogged.

The tubular connector 40, union device 42, y-port connector 44, catheterand tip 60 can be made from any suitable polymer or plastic materialincluding, but not limited to, polyamide, polyethylene, polypropylene,polyurethane, silicone and polyacrylonitrile.

B. Signal Generating Assembly

As best illustrated in FIGS. 14-21, in one embodiment, the invasivesignal generating assembly 16 includes: (a) a controller coupler or anelectrical connector 36 operatively connected to the electricalextension 34; (b) an elongated wire assembly 38 operatively coupled tothe connector 36; (c) a wire or elongated stiffener 39 attached to theconnector 36 and serving as a support for the wire assembly 38; (d) amagnetic energy generator or magnetic field generator 58 operativelycoupled to the distal end of the wire assembly 38; and (e) a suitablefastener attaching the distal end of the elongated stiffener 39 to themagnetic field generator 58. The tubular insulator 40 described abovecovers a portion 41 of the wire assembly 38 positioned adjacent to theconnector 36.

1. Electrical Connector

As best illustrated in FIGS. 16-18, in one embodiment, the electronic orelectrical connector 36 includes: (a) a top wall or surface 186; (b) aside wall or surface 188 attached to the top surface 186; (c) a bottomwall or surface 189 attached to the side wall 188; (d) an electroniclead assembly or electronic connector 190, such as a circuit board 191,positioned between the top surface 186 and the bottom surface 189; and(e) fasteners 192 and 194 attaching the top surface 186 to the bottomsurface 189. It should be appreciated that various fasteners may be usedto secure the top surface 186 to the bottom surface 189. The fasteners192 and 194 may be mechanical or chemical. Mechanical fasteners may, forexample, include snaps, screws, rivets or other suitable fasteners.Chemical fasteners may include, for example, adhesives, chemical bonds,weld bonds or moldings suitable for securing the top surface 186 and thebottom surface 189 together. Although the embodiment illustrated in FIG.16 has multiple fasteners 192 and 194 passing through the circuit board191, it should be understood that, in other embodiments, a singlefastener may securely position the circuit board 191 between the twosurfaces 186 and 189.

The circuit board 191, in one embodiment, includes: (a) contact members196 and 198 extending across a portion 193 of the circuit board 190; and(b) a reserve contact member 200 extending across the circuit board 190.The contact members 196, 198 and 200 can be made from any conductivematerials. When the electronic connector 190 is connected to theelectrical extension 34, the contact members 196, 198 and 200 areoperatively coupled to the apparatus 10 of the system 2. Therefore, thecontact members 196 and 198 transmit electrical current from theapparatus 10 to the magnetic energy generator or magnetic fieldgenerator 58 described below.

2. Wire Assembly

As best illustrated in FIGS. 16, 18 and 21, in one embodiment, the wireassembly 38 includes: (a) an elongated flexible conductor such as acopper wire 202 having a proximal end 206 connected to the circuit board190 and a distal end 251 connected to the magnetic field generator 58;and (b) another elongated flexible conductor such as a copper wire 204having a proximal end 212 connected to the circuit board 190 and adistal end 253 connected to the magnetic field generator 58. In oneembodiment, the copper wire 202 and copper wire 204 include a polymericcoating 218. The proximal end 206 of the copper wire 202 is operativelycoupled to an extension 197 of the contact member 196 of the circuitboard 191. Likewise, the proximal end 212 of the copper wire 204 isoperatively coupled to an extension 199 of the contact member 198 of thecircuit board 191. The copper wires 202 and 204 can be soldered to theappropriate contact members 196 and 198 or attached by any suitablefastener.

In one embodiment described below, the distal ends 251 and 253 of thecopper wires 202 and 204 have a coil configuration forming coils 250thereby producing a magnetic field generator 58 as described below. Thecoil 248 is formed from a plurality of spirals 252 produced by wrappinga portion 249 of the copper wire 204 around the magnetic field generator58 as described below.

Referring back to FIG. 16, the copper wire 202 and the copper wire 204are twisted around each other along the lengths 210 and 216 to form atwisted configuration 217. In one embodiment, the copper wires 202 and204 are twisted a suitable number of times along the lengths 210 and216. The twisted configuration 217 reduces any electromagnetic fieldsurrounding the wires 202 and 204 along the twisted lengths 210 and 216.This reduction is caused by the counteraction of the electromagneticforces of the electrical wires 202 and 204. Accordingly, the hand-heldtransceiver 32 receives less, if any, signal interference arising fromany electromagnetic fields generated by the wire assembly 38.

As illustrated in FIG. 18, in one embodiment, the elongated stiffener 39includes a bend or center portion 228. The elongated stiffener 39 ispreferably made of steel but can be made of any other suitable material.The center portion 228 of the elongated stiffener 39 is looped aroundthe fastener 192 of the connector 36 forming a segment 230 and a segment232. The segments 230 and 232 are twisted around each other forming atwisted configuration 234. The twisted configuration 234 increases therigidity of the elongated stiffener 39. In one embodiment, the wireassembly 38 is twisted into the grooves 219 of the twisted configuration234. This increases the space efficiency of the wire assembly 38 and theelongated stiffener 39 positioned within the tubing assembly 14. Theincrease in space efficiency is a result of reducing the overalldiameter 110 of the wire assembly 38, as illustrated in FIG. 7.

3. Signal Generator

As best illustrated in FIG. 20, in one embodiment, the signal generatoror magnetic field generator 58 is formed through a plurality of spiralsor coils 250 of the wires 202 and 204. As the apparatus 10 transmitselectrical current through the wires 202 and 204, the current travels ina circular path defined by the coils 250. This circular motion ofcurrent produces an electromagnetic field, B field or electromagneticradiation 258. Although the embodiment illustrated includes the coils250 as the magnetic field generator 58, it should be appreciated thatthe magnetic field generator 58 can include any alternate suitablemechanism or device which generates or produces magnetic energy or amagnetic field. In one embodiment, the magnetic field generator 58includes a magnet such as a permanent magnet, resistive magnet orsuperconducting magnet.

In operation, when the apparatus 10 sends electrical current to thecoils 250, and the coils 250 transmit a signal or electromagnetic field258 capable of being detected by the non-invasive transceiver 32. Thetransceiver 32 detects the electromagnetic field or signal 258 generatedby the magnetic field generator 58 inside the human body. The processor20 causes the display device 22 and the printer 28 to produce graphicswhich assist the health care provider in the catheter placementprocedure.

C. Method of Controlling Placement of Signal Generator

As illustrated in FIGS. 21-25, several difficulties could arise if acatheter assembly 300 does not have the stop member 132 and positionadjuster or controller 120 of the union member 42 of the presentinvention. For example, a catheter procedure may involve positioning thetip 60 of a catheter 50 to a desired location. During the manufacturingprocess for the catheters 50, the catheters 50 may have lengthvariations V₁, V₂ and V₃ ranging up to one and one-fourth of an inch. Inone embodiment, catheters 50 are constructed of a polyurethane materialwhich provides the catheters 50 with a tendency to expand or contractduring or after the manufacturing process thereby causing suchvariations. If one of the catheters 50 is too long, the magnetic fieldgenerator 58 could protrude through the tip 60 as illustrated in FIG.21. If one of the catheters 50 is too short, the magnetic fieldgenerator 58 could substantially stop short of the tip 60 as illustratedin FIG. 22. This may result in a decrease in reliability of theinformation and graphics provided by the catheter position guidancesystem 2 of the present invention.

The system 2 is more helpful when the magnetic field generator 58 ispositioned at or near the tip 60 of the catheter 50. This positioninghelps maintain an adequate level of reliability of guidance informationprovided by the system 2. In the embodiments best illustrated in FIGS.1-20 and 23-25, the union device 42 assists in maintaining the positionof the magnetic field generator 58 at or near the tip 60. The use of theunion device 42, in one such embodiment, reduces the likelihood that themagnetic field generator 58 might protrude through the tip 60 or stopsubstantially short of the tip 60. Therefore, the union device 42functions as a generator placement control device. In one embodiment,this placement and control function of the union device 42 is adjustableto conform to catheters 50 that have different lengths.

As best illustrated in FIGS. 24-25, the union device 42 has a proximalend 116, a distal end 118 and a position controller, position adjusteror elongated neck 120. The proximal end 116 is movably coupled to thedistal end 102 of the tubular insulator 40. The position adjuster orelongated neck 120 defines a passage 134 which provides the positionadjustment function or adjustment device of the union device 42. Theuser can adjustably position the second end 102 of the tubular insulator40 to a plurality of different locations 138 (for example, L₁-L₃) alongthe passage 134. Once the user determines the proper location 138, theuser fixes the tubular insulator 40 to the position adjuster 120 at thatselected location. The position may be fixed using an adhesive, clip,clasp, tape or any other suitable fastener. Because the tubularinsulator 40 is connected to the electrical connector 36 which, in turn,is connected to the magnetic field generator 58, the fastening of thetubular insulator 40 to the proper location on the position adjuster 120assists in the proper positioning of the magnetic field generator 58relative to the tip 60 of the catheter 50. This allows the user toposition the magnetic field generators 58 at a desired or designatedlocation relative to the end members or tips 60 of catheters 50 ofvarious lengths. Thus, users can use the system 2 with manufacturedcatheters 50 having various lengths.

In one example, the method of controlling the placement of the generator58 includes first step of determining the length of the catheter 50.Next, prior to placing the catheter 50 into the human body for enteralor parenteral feeding, the user or assembler places the magnetic fieldgenerator 58 at a desired location within the catheter 50. Finally, theassembler locks this placement by fastening the tubular insulator 40 tothe union device 42 using a suitable adhesive.

Once the position of the generator 58 has been properly set, the healthcare provider places the transceiver 32 on the patient's chest andinserts the catheter 50 into the body. While doing so, the displaydevice 22 displays graphics 37 that help the user in guiding thecatheter tip 60 to a desired location within the human body. Once thecatheter 50 is placed in the desired location, the user removes thesignal generating assembly 16 while the position of the catheter 50 ismaintained. The user then attaches medicine and nutritional deliverytubes to the y-port connector 44 for introducing fluids into the bodyfor medical treatment.

It should also be understood that, in alternate embodiments, theelectronic catheter unit of the present invention need not include thegenerator position control device described above. Here, the assemblersmay measure each catheter and disregard each catheter that is too longor too short. It should be appreciated that other assembly processes andmechanisms may be used to control the proper location of the fieldgenerator 58 relative to the catheter tip 60.

It should also be appreciated that the tubing assembly, electroniccatheter unit and catheter position guidance system of the presentinvention can be used in a variety of catheter procedures andapplications. These procedures may involve the treatment of thegastrointestinal tract, cardiovascular system or other portions of thehuman body. These procedures may involve treatment of humans byphysicians, physician assistants, nurses or other health care providers.In addition, these procedures may involve treatment of other mammals andanimals by veterinarians, researchers and others.

The present invention, in one embodiment, includes a tubing assembly andsignal generator for an electronic catheter unit of a catheter positionguidance system. The tubing assembly and signal generator are used inconjunction with other components of the system to assist the user inperforming a catheter placement procedure. The tubing assembly has aposition controller which enables the system to be used with cathetersof variable lengths. Therefore, the tubing assembly and the positioncontroller, used in conjunction with the catheter position guidancesystem of the present invention, provide an enhancement in medicaltreatment.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present invention andwithout diminishing its intended advantages. It is therefore intendedthat such changes and modifications be covered by the appended claims.

1. A tubing assembly for use in conjunction with an invasive signalgenerator, the tubing assembly comprising: a connector configured toconnect to the invasive signal generator; a magnetic field generator; atleast one elongated electrical conductor connecting the connector to themagnetic field generator, the at least one elongated electricalconductor having a diameter; a tubular insulator having a first end, asecond end, an internal diameter and an external diameter, said firstend attachable to the connector, the internal diameter of the tubularinsulator being substantially equal to or greater than the diameter ofthe at least one elongated electrical conductor, the at least oneelongated electrical conductor extending through the internal diameterof the tubular insulator; a union device having a first end, a secondend, an elongated neck, a gripping member, an insert and an internalsurface, the first end of the union device being coupled to the secondend of the tubular insulator, the internal surface having a stop, theelongated neck, gripping member and insert being positioned between thefirst and second ends, the first and second ends each having an internaldiameter and an external diameter, the internal diameter of said firstend of the union device being substantially equal to or larger than theexternal diameter of the second end of the tubular insulator; a y-portconnector defining a medicine branch, a feeding branch, a connectionbranch and a plurality of movable arms, the feeding branch sized toreceive the insert of the union device, each of the movable arms havinga stopper; a feeding tube including a body having a first end, a secondend and an external surface, said first end being attached to theconnection branch of the y-port connector, the external surface having aplurality of designated unit markings uniformly spaced along the body ofthe feeding tube; and a tip attached to the second end of the feedingtube, the tip including a body having a collar and an end member, thebody defining a passage and an opening, the opening positioned betweenthe collar and the end member, a portion of the end member having arounded shape.
 2. The tubing assembly of claim 1, which has a fastenersecuring the tubular insulator in direct contact with an adjustablypositionable location on the elongated neck.
 3. The tubing assembly ofclaim 1, wherein the gripping member of the union device includes aplurality of ribbed members.
 4. The tubing assembly of claim 2, whereinthe elongated neck and the fastener include a position controller. 5.The tubing assembly of claim 4, wherein the fastener includes anadhesive.
 6. The tubing assembly of claim 1, wherein the union deviceincludes a stop positioned on the internal surface of the union device.7. A tubing assembly for use in conjunction with: (a) an invasive signalgenerator; and (b) one of a plurality of feeding tubes, each of thefeeding tubes having an end member and being of a different length, thetubing assembly comprising: a magnetic field generator; at least oneelongated electrical conductor having a first end, a second end and adiameter, the first end including a connector configured to connect tothe invasive signal generator, the second end being connected to themagnetic field generator; a tubular insulator having a first end and asecond end, said first end attachable to the first end of the at leastone elongated electrical conductor so that the connector is connectibleto the invasive signal generator; a union device having a first end, asecond end and a neck positioned between the first end and the secondend, said first end being movably coupled to the second end of thetubular insulator, the neck defining a passage, the second end of thetubular insulator adjustably positionable to a plurality of differentlocations along the passage so that the magnetic field generator ispositionable at a desired location relative to the end member of any oneof the feeding tubes; a fastener securing the tubular insulator to theneck of the union device at one of the different locations to positionthe magnetic field generator at the desired location; and a multi-wayconnector defining a plurality of branches, a first one of the branchesof the multi-way connector attachable to the second end of the uniondevice.
 8. The tubing assembly of claim 7, wherein the fastener includesa device selected from the group consisting of an adhesive, a clip, apin and tape.
 9. The tubing assembly of claim 7, wherein the uniondevice includes a gripping member having a plurality of ribbed members.10. The tubing assembly of claim 7, which includes a tube-size adapter.11. The tubing assembly of claim 10, wherein the multi-way connector hasat least one movable arm, wherein at least one section of the movablearms engages with the tube-size adapter.
 12. The tubing assembly ofclaim 7, which includes a catheter in fluid communication with themulti-way connector.